Technical operations personnel – “Tech Ops” – can feel like they are running in circles as much as advancing programs forward. To straighten out those loops, Arena Pharmaceuticals relies on Doug Bakan, EVP Technical Operations. But complicating matters for Bakan is that today Arena is an all-outsourcing development and manufacturing organization.
The primary business case for blockchain in the pharmaceutical industry is its ability to serve as a “ledger of truth” when complex information needs to be shared with business partners across the supply chain, including those unique to life sciences, such as regulators, pharmacy benefit managers, and contract manufacturers.
Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.
Bioburden is that dirty little topic nobody wants to talk about in mixed company (operations and QA) — a contamination that can get into our products at several entry points. Our fundamental responsibility is to eradicate it, but since it is invisible, we often make believe it doesn’t exist.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
Choosing an offsite storage facility means asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment.
When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved.
Proper management of membership data poses a significant operational challenge for pharmaceutical manufacturers. Membership data is submitted by wholesaler, distributor and Group Purchasing Organization (GPO) customers in the form of “rosters” that are used by manufacturers to determine eligibility for contract sales when adjudicating chargeback and rebate transactions. Membership data also serves a second -- and equally critical purpose -- to assist manufacturers in designating customer trade class for use in regulated price reporting and sales and marketing activities.
The first challenge in managing membership data is addressing the overwhelming volume of data received. Most often, rosters are sent via email to a processing specialist in the contracts and/or chargeback processing area. A full listing is provided at the inception of the contract, and then updates detailing additions, changes and deletions to the listing are provided on a periodic basis, typically monthly. The data then has to be aggregated, cleansed and added to the company’s customer master before it can be used to process transactions. Even if the member has been previously recorded in the customer master, the accuracy of assignment cannot be guaranteed because a change or deletion may have been submitted by a wholesaler, distributor or GPO client for the current reporting period.
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.
The success of a drug candidate to reach the market requires a rigorous investigation into its toxicological profile. Therefore, ADME (Absorption, Distribution, Metabolism and Excretion) studies must be executed at an early stage in the clinical development of the investigational drug.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.
Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.
When selecting a bioreactor, It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
